Objective Assessment of Intraocular Lens Tilt and Decentration

NCT ID: NCT07324200

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-22

Study Completion Date

2026-02-23

Brief Summary

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Prospective, multi-center, non-interventional, open label, randomized clinical study.

Detailed Description

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The objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.

Conditions

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Tilt and Decentration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TECNIS refractive non-toric IOL models

The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive non-toric IOL models.

OCT Imaging Test

Intervention Type DIAGNOSTIC_TEST

The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.

TECNIS diffractive non-toric IOL models

The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS diffractive non-toric IOL models.

No interventions assigned to this group

Interventions

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OCT Imaging Test

The primary objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Basic Science

Eligibility Criteria

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Inclusion Criteria

1. Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms.
2. Appear capable and willing to adhere to the clinical protocol instructions.
3. Be 22 years of age or older at the time of screening.
4. Have undergone unilateral or bilateral implantation with a desired non-toric TECNIS IOL design (e.g., refractive or diffractive).
5. At least three months postoperative in the eligible eye.

Exclusion Criteria

1. Any medical or ocular history, in the opinion of the investigator, that may impact study procedures such as ocular trauma, pseudoexfoliation syndrome, retinal pigment degeneration, macular pathology, glaucoma, retinal disease, corneal disease, or corneal opacities.
2. Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
3. Have a history of corneal or intraocular surgery other than cataract surgery.
4. Using ocular or systemic medications known to interact with dilation drops.
5. Have a history of allergic reactions to dilation drops.
6. Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
7. Has an intraocular pressure of ≥ 21mm Hg before mydriasis.
8. Have a mydriatic pupil diameter of less than 6 mm.
9. Have participated in a clinical trial within 7 days prior to study enrollment.
10. An employee (e.g., Investigator, Coordinator, or Technician) or immediate family member (including partner, child, parent, grandparent, grandchild, or sibling) of an employee of the clinical site or study sponsor.
11. Currently pregnant or lactating.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Surgical Vision Inc. Johnson and Johnson

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Empire Eye & Laser Center

Bakersfield, California, United States

Site Status

Jones Eye Center

Sioux City, Iowa, United States

Site Status

Countries

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United States

Central Contacts

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Siddhesh Raorane

Role: CONTACT

904-539-7205

Kristen Leraas

Role: CONTACT

Facility Contacts

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Daniel Chang

Role: primary

661-325-3937

Jason Jones

Role: primary

712-239-3937

Other Identifiers

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MDEV113OCTI

Identifier Type: -

Identifier Source: org_study_id

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